The aim was to evaluate the effectiveness, safety and economic impact of long-acting insulin analogues (LAIA) compared to NPH for type 1 diabetes mellitus (DM1).

A search was performed in five electronic databases to find systematic reviews (SR) comparing at least a LAIA to NPH insulin for DM1. Budget impact analysis was performed from the perspective of Brazilian public health system (SUS), with NPH insulin as the base scenario. The costs were extracted from the Integrated System of Administration of General Services (SIASG). The market share was calculated per month, using a logarithmic function with maximum diffusion of 50% at the end of the time horizon - five years.

A total of 160 studies were identified and seven SR of low to uncertain risk of bias were selected. LAIA have shown modest clinical benefit and its effect is more prominent for the control of severe and nocturnal hypoglycaemia. Insulins glargine and detemir compared to NPH were associated with reduction in HbA1c levels between 0.16% and 0.40% and associated with lower risk of episodes of severe hypoglycemia. Insulin degludec compared to NPH showed no statistically significant difference in the reduction of HbA1c levels and in the episodes of severe hypoglycemia. The budget impact ranges from USD 210 million (detemir) to USD 670 million (degludec) over five years.

The use of LAIA as a basal insulin regimen for DM1 may benefit more patients with recurrent episodes of hypoglycemia. However, the fragility of the outcomes considered to evaluate the clinical impact of LAIA and the high budget impact with its use should be considered, and may compromise SUS sustainability. In view of these aspects, CONITEC recommended the incorporation of one of the LAIA, if the treatment is equal to or less than that of NPH insulin and according to the criteria established by a guideline.